DRUG SAFETY AND RISK ASSESSMENT IN DRUG USE

Course Description

This course covers introduction to drug safety and fundamental concepts, adverse drug reactions, pharmacovigilance, history of pharmacovigilance, pharmacovigilance centers, sources of generation of safety signals, cause and effect analysis, hypersensitivity, immunotoxicity and idiosyncratic reactions, toxic responses of the skin to drugs and cosmetics, the role of cytochromes in liver diseases/toxicities, factors affecting toxicity of herbal medicinal products and their interaction with drugs, most commonly used herbal preparations and their specifications, safety in polypharmacy and the measures taken for the efficacy of the drugs with respect to patient safety, impact of drug metabolizing enzyme polymorphisms in drug response, toxicities due to the genetic and inter-individual differences, drug-nutrient interactions and their consequences, risk assessment of chemicals and drug use, medication errors and patient safety.

DRUG SAFETY AND RISK ASSESSMENT IN DRUG USE

Evaluation Tools (Active Term)

Course outcomes

1. 01 1.Be able to classify the types of adverse drug reactions and assess the clinical and toxicological consequences.
2. 02 2.Be able to Identify and explain the need for Pharmacovigilance system and evaluate and compare the adverse drug reaction reporting systems.
3. 03 3.Be able to explain drug-drug, drug-herbal product, drug-environmental chemical interactions and assess the clinical and toxicological consequences.
4. 04 4.Be able to desribe the basic principles of risk assessments of chemicals and medications and explain the risk management of medications.
5. 05 5.Be able to Identify the medication errors and explain the management of these errors with respect to patient safety.

Course Syllabus

Reference Books & Course Materials

1. 01 Klaasen CD, Watkins JB. Casarette & Doull’s Essentials of Toxicology. McGraw-Hill Comp., North America, 2010.
2. 02 Coleman MD. Human Drug Metabolism, Wiley-Blackwell, Oxford, 2010
3. 03 Boulatta JI, Armenti. Handbook of drug nutrient interactions, Humana Press, USA. 2020
4. 04 AHPA's Botanical Safety handbook, 2nd ed., North America, 2013

Learning Outcomes

1. L01 Classify (3) the types of adverse drug reactions and assess (5) the clinical and toxicological consequences SOLO 4
2. L02 Identify (2) and explain (3) the need for Pharmacovigilance system and evaluate (4) and compare (5) the adverse drug reaction reporting systems. SOLO 3.5
3. L03 Explain (3) drug-drug, drug-herbal product, drug-environmental chemical interactions and assess (5) the clinical and toxicological consequences SOLO 4
4. L04 Describe (3) the basic principles of risk assessments of chemicals and medications and assess (5) the risk and management of medications SOLO 4
5. L05 Describe (3) the medication errors and evaluate (4) the management of these errors with respect to patient safety SOLO 3.5

Program Outcomes

1. P01 Gain the ability to apply the Pharmacy profession.
2. P02 Interpret the accuracy and reliability of the current theoretical and practical knowledge in the field of pharmacy, as well as being able to follow and evaluate innovations.
3. P03 Practically apply the knowledge they gain on pharmaceutical sciences. The acquired knowledge and skills allow the graduates to act as the closest health consultant to the public with the ability to inform the public.
4. P04 Evaluate and apply current technology related to basic subjects and principles covering pharmacy and health sciences and take part in in-service training seminars.
5. P05 Know the risks and evaluation of the use of drugs and other chemicals and safe laboratory practices (GMP).
6. P06 Acquire the ability to interpret the findings obtained by qualitative and quantitative measurements and to reach valid scientific results from the data.
7. P07 Prepare pharmaceuticals and provide guidance on the use of pharmaceutical products.
8. P08 Design research and develop projects related to pharmaceutical products; manage and share the results.
9. P09 Be competent to accurately and intelligibly communicate and transfer knowledge about prescription content and pharmaceutical products to the patient / user. The graduates are trained on taking necessary precautions for safe drug usage and encouraging rational drug use, as well as providing consultancy and supervision.
10. P10 Work in an interdisciplinary environment. Graduates can cooperate with other professional groups, participate in vocational training and activities, have proper knowledge and communication skills.
11. P11 Take part in social responsibility projects related to health. Graduates have awareness on sustainable environment and participate in activities and practices related to their profession.
12. P12 Open a community pharmacy, also work in hospital pharmacies, can work in different fields related with pharmaceuticals, cosmetics, medical and herbal products, as well as production and quality control in the pharmaceutical industry. Takes part in the professional development of herself/himself, her/his colleagues and pharmacy students.
13. P13 Implements the legal and professional law and ethics as a health professional, in issues concerning public health.
14. P14 Knows and applies the processes related to drug design from natural or synthetic sources, as well as development, preparation, analysis and metabolism of drugs in the human body.

Po-Lo Matrix